SOLICITATION NOTICE
65 -- NX EQ Auditory Function Screening Device
- Notice Date
- 12/13/2021 9:07:19 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- STRATEGIC ACQUISITION CENTER FREDERICKSBURG (36C10G) FREDERICKSBURG VA 22408 USA
- ZIP Code
- 22408
- Solicitation Number
- 36C10G22Q0016
- Response Due
- 1/13/2022 8:59:00 PM
- Archive Date
- 04/22/2022
- Point of Contact
- Ninatile Bacote, Contract Specialist, Phone: 202-957-2173
- E-Mail Address
-
Ninatile.Bacote@va.gov
(Ninatile.Bacote@va.gov)
- Awardee
- null
- Description
- Solicitation Number: 36C10G22Q0016 Notice Type: Combined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number 36C10G22Q0016 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2021-07, dated 10 September 2021. Requirement Description: VA has a requirement to purchase Auditory Function Screening Devices to deliver patient care at its VA Medical Centers around the country. Auditory Function Screening Devices are used for evaluating hearing acuity. Auditory Function Screening Devices usually consist of an embedded hardware unit connected to a pair of headphones and a test subject feedback button, sometimes controlled by a standard PC. There are five different Auditory Function Screening Devices, and these devices are targeted at specific evaluations. A Mid-level Audiometer, a Middle Ear Analyzer, a Two Channel Clinical Audiometer, a Otoacoustic Emissions, an Evoked Potential Screener, and a Pure Tone & Tympanometry Screener. A single award Requirements contract will be awarded for the purchase of brand name or equal equipment in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the band name or equal equipment. The Government reserves the right to award without discussions. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as full and open competition. This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Grason-Stadler GSI brand name or equal Auditory Function Screening Devices and related equipment and accessories as identified in ATTACHMENT A NX EQ AUDITORY FUNCTION SCREENING DEVICES PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A NX EQ AUDITORY FUNCTION SCREENING DEVICES PRICE COST SCHEDULE. The ordering period is for one year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities. The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached. All interested quoters must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/. Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on December 27, 2021 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov. No calls will be accepted. Quotes are due via email by 11:59PM EST on January 13, 2022 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov. 1. SCOPE OF WORK: The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified has identified the Auditory Function Screening Device product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract. Auditory Function Screening Device are used for evaluating hearing acuity. Auditory Function Screening Devices usually consist of an embedded hardware unit connected to a pair of headphones and a test subject feedback button, sometimes controlled by a standard PC. There are five different Auditory Function Screening Devices, and these devices are targeted at specific evaluations. A Mid-level Audiometer, a Middle Ear Analyzer, a Two Channel Clinical Audiometer, a Otoacoustic Emissions, an Evoked Potential Screener, and a Pure Tone & Tympanometry Screener. The Auditory Function Screening Device required for this program have been identified as most advantageous to the Government to be incorporated into a national Requirements contract. The salient characteristics (SC) for these commercial items are identified in the Auditory Function Screening Device Product Description. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Auditory Function Screening Device to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period with four 12-month option periods. 2. REQUIREMENT This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the Grason-Stadler GSI® brand name Auditory Function Screening Device. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. CLINS MFG P/N DESCRIPTION 0001 Grason-Stadler GSI 39 The GSI 39 Auto Tympanometry provides a flexible, screening product for tympanometry, acoustic reflex measurements and audiometry to meet testing needs today and in the future. The product is available in five different versions to meet the unique demands of each facility. All five versions are fast, versatile and easy to use. It is possible to add additional modalities such as audiometry, contralateral reflexes or 1,000 Hz probe tone as the facility testing requirements expand. 0001-01 Grason-Stadler 8514899 GSI 39 Auto Tymp - Version 1 - 226 Hz Tymp & Ipsi Reflex 0001-02 Grason-Stadler 8514900 GSI 39 Auto Tymp - Version 1 226 Hz + 1 kHz Tymp & Ipsi Reflex 0001-03 Grason-Stadler 8514901 GSI 39 Auto Tymp - Version 2 - 226 Hz Tymp with Ipsi Reflex & Contra Reflex 0001-04 Grason-Stadler 8514902 GSI 39 Auto Tymp - Version 2 - 226 Hz + 1 kHz Tymp with Ipsi Reflex & Contra Reflex 0001-05 Grason-Stadler 8514903 GSI 39 Auto Tymp - Version 3 - 226 Hz Tymp with Ipsi & Contra Reflex & Pure Tone Audiometry 0001-06 Grason-Stadler 8514904 GSI 39 Auto Tymp - Version 3 - 226 Hz + 1 kHz Tymp with Ipsi & Contra Reflex & Pure Tone Audiometry 0001-07 Grason-Stadler 8514905 GSI 39 Auto Tymp -Version 4 - 226 Hz Tymp with Ipsi Reflex & Pure Tone Audiometry 0001-08 Grason-Stadler 8514906 GSI 39 Auto Tymp - Version 4 - 226 Hz + 1 kHz Tymp with Ipsi & Pure Tone Audiometry 0001-09 Grason-Stadler 8514907 GSI 39 Auto Tymp - Version 5 - 226 Hz Tymp Only 0001-10 Grason-Stadler 8514908 GSI 39 Auto Tymp - Version 5 - 226 Hz + 1 kHz Tymp Only 0002 Grason-Stadler GSI 39 Upgrade Options 0002-01 Grason-Stadler 8020194 GSI 39 From 226Hz to 226 Hz+1000 probe 0002-02 Grason-Stadler 8020195 GSI 39: 226Hz Version 1 to 226 Hz Version 2 0002-03 Grason-Stadler 8020196 GSI 39: 226Hz Version 1 to 226 Hz Version 3 0002-04 Grason-Stadler 8020197 GSI 39: 226Hz Version 1 to 226 Hz Version 4 0002-05 Grason-Stadler 8020198 GSI 39: 226Hz Version 2 to 226 Hz Version 3 0002-06 Grason-Stadler 8020199 GSI 39: 226Hz Version 4 to 226 Hz Version 3 0002-07 Grason-Stadler 8020200 GSI 39: 226Hz Version 5 to 226 Hz Version 1 0002-08 Grason-Stadler 8020201 GSI 39: 226Hz Version 5 to 226 Hz Version 2 0002-09 Grason-Stadler 8020202 GSI 39: 226Hz Version 5 to 226 Hz Version 3 0002-10 Grason-Stadler 8020203 GSI 39: 226Hz Version 5 to 226 Hz Version 4 0003 Grason-Stadler GSI AudioStar Pro GSI AudioStar Pro is a versatile two-channel clinical audiometer designed to perform efficient audiometric evaluations on every patient population. It may be used independently or with a computer for HIPAA compliant data storage and EMR/EHR compatibility. 0003-01 Grason-Stadler 8518227 AudioStar Pro with DD45, B81, IP30 and DD450 Transducers with GSI-AMTAS Automated Audiometry. (Does Not Include Computer.) 0003-02 Grason-Stadler 8518226 AudioStar Pro with DD45, B81, IP30 and DD450 High Frequency Headphones 0003-03 Grason-Stadler 8515319 AudioStar Pro with DD45, B81 and IP30 Insert Earphones 0004 Grason-Stadler GSI AudioStar Pro GSI AudioStar Pro Options 0004-01 Grason-Stadler 8102475 Basic Speaker Kit with cable, 90 dB HL 0004-02 Grason-Stadler 8013647 High Performance Speaker Kit with cables, 96 dB HL 0004-03 Grason-Stadler 8103808 High Performance Speaker Kit with Booster Amplifier and cables, 100 dB HL - US Power Cord 100V to 240V 0004-04 Grason-Stadler 8100465 Isolation Transformer (Required When the GSI AudioStar Pro or the GSI Pello is Attached to a Booster,PC or Printer 0004-05 Grason-Stadler 8503180 Touch screen PC for use with GSl-AMTAS 0004-06 Grason-Stadler 8503192 GSl-AMTAS Upgrade kit (for existing AudioStar Pro) - see GSl-AMTAS requirements specifications. NOTE: System Serial Number and License Number required for Upgrade 0005 Grason-Stadler GSI AudioStar Pro GSI AudioStar Pro Supplies 0005-01 Grason-Stadler 8109155 AMBAND - Calibrated Bone Conduction Headbands (10) 0005-02 Grason-Stadler 8507203 Earphone Y-Cable (L and R) 0005-03 Grason-Stadler 8507208 P3045 Headband Only (Adult) 0005-04 Grason-Stadler 8507210 P3100 Pediatric Headband 0005-05 Grason-Stadler 8010894 Type 51 Earphone Cushion, Single 0005-06 Grason-Stadler 8104119 Bone Vibrator Assembly , B71,SO ohm 0005-07 Grason-Stadler 8101884 IP30 Insert earphones, 10 ohm 0005-08 Grason-Stadler 8520321 DD45O Headphones for High Frequency Audiometry (8000-20,000 Hz) and GSl-AMTAS 0005-09 Grason-Stadler 8503852 DD45 Audiometric Headset P3100 (Pediatric) Replacement Kit 0005-10 Grason-Stadler 8503851 DD45 Audiometric Headset P3045 (Adult) Replacement Kit 0006 Grason-Stadler GSI AudioStar Pro GSI AudioStar Pro CD s and Accessories 0006-01 Grason-Stadler 8515177 AudioStar Pro Software and Manuals, USB Bundle 0006-02 Grason-Stadler 8519002 Calibration App with Service Manual, English, USB 0006-03 Grason-Stadler 8518110 Talk Back Microphone (TB-2) with mounting bracket 0006-04 Grason-Stadler 8004361 Basic speaker cable for GSI AudioStar Pro 0007 Grason-Stadler GSI Audera The GSI Audera meets all of your needs for Evoked Potential testing by providing a unique combination of Auditory Evoked Potentials (AEP), Otoacoustic Emissions (OAE), and Auditory Steady State Response (ASSR) tests. Available with CE-Chirp and CE-Chirp Octave Band stimuli for frequency-specific threshold evaluations. 0007-01 Grason-Stadler 8519280 GSI Audera Pro - AEP/ASSR 0007-02 Grason-Stadler 8519281 GSI Audera Pro - AEP/OAE 0007-03 Grason-Stadler 8519282 GSI Audera Pro - AEP Only 0007-04 Grason-Stadler 8519283 GSI Audera Pro - OAE Only 0007-05 Grason-Stadler 8517151 GSI Audera Pro - Full Configuration (AEP/ASSR/OAE) 0008 Grason-Stadler GSI Corti The GSI Corti is a portable, battery-operated diagnostic and screening instrument that measures Otoacoustic Emissions (OAE) for infants, children, and adults. The Corti offers maximum speed and flexibility with pre-defined and user-defined protocols for Distortion Product Otoacoustic Emissions (DPOAEs) and Transient Evoked Otoacoustic Emissions (TEOAEs) measurements. 0008-01 Grason-Stadler 8104314 GSI Corti DPOAE Screening Unit 0008-02 Grason-Stadler 8104315 GSI Corti TEOAE Screening Unit 0008-03 Grason-Stadler 8104316 GSI Corti DPOAE + TEOAE Screening Unit 0008-04 Grason-Stadler 8104317 DPOAE Diagnostic Unit (Includes DPOAE Screening) 0008-05 Grason-Stadler 8104318 TEOAE Diagnostic Unit (Include TEOAE Screening) 0008-06 Grason-Stadler 8104319 DPOAE + TEOAE Diagnostic Unit (Includes DP and TE Screening) 0009 Grason-Stadler GSI Tympstar Pro GSI TympStar Pro offers comprehensive middle-ear testing capabilities that support the needs of hearing healthcare professionals. Change parameters on the fly or interpret results with the touch screen display. Protocols may be configured to optimize efficiency and workflow; the flexibility of pre-defined protocols saves time and creates consistency in testing procedures. 0009-01 Grason-Stadler 8108266 TympStar Pro Comprehensive Middle Ear Analyzer, Probe Assembly (226 Hz, 678 Hz and 1000 Hz) and Contra Phone 0010 Grason-Stadler GSI Tympstar Pro GSI Tympstar Pro Options 0010-01 Grason-Stadler 8109043 HP Office Jet Printer {6230 or equivalent) 0010-02 Grason-Stadler 8108894 Metal Test Cavities 0010-03 Grason-Stadler 8100465 Isolation Transformer (required when the GSI AudioStar Pro or the GSI Pello is attached to a Booster,PC or printer per UL/IEC/CSA 60601-1) 0011 Grason-Stadler GSI Tympstar Pro GSI Tympstar Pro Supplies 0011-01 Grason-Stadler 8109405 Probe Tip Replacement Kit (3) 0011-02 Grason-Stadler 8108944 Probe Floss Cleaning Kit 0012 Grason-Stadler GSI Tympstar Pro GSI Tympstar Pro CD s and Accessories 0012-01 Grason-Stadler 8108329 TympStar Pro Software and Manuals, USB Bundle 0012-02 Grason-Stadler 8503354 Calibration App with Service Manual, English, USB 0013 Grason-Stadler Installation and Training 0013-01 Grason-Stadler GSI-INSTALL-ASP Grason-Stadler Audio Star Pro Installation, Calibration & Training 0013-02 Grason-Stadler GSI-INSTALL-CORTI Grason-Stadler Corti Installation and Training 0013-03 Grason-Stadler GSI-INSTALL-TSP Grason-Stadler TympStar Pro Installation, Calibration & Training 0013-04 Grason-Stadler GSI-INSTALL-UPGRADE GSl-AMTAS Upgrade Kit Installation The Department of Veterans Affairs (VA) is seeking vendors who can provide Grason-Stadler GSI® brand name Auditory Function Screening Device as listed above or equal commodities which meet all of the following salient characteristics. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Vendors are asked to quote any additional product that may be beneficial. These items must be captured in the vendor s pricing volume. CLIN s 0001-0002 apply to the following salient characteristics for Auditory Function Screening Devices. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 1 Must have Tympanometry min 226 Hz - 1,000Hz. Literature Review SC 2 Contralateral reflex measurements up to 1,000 Hz, offers probe tone. Literature Review SC 3 Must be able to perform automated audiometry, advantageous to perform manually. Literature Review SC 4 Must test in IPSI and contralateral reflex measurements. Literature Review SC 5 Must have print formats. Literature Review CLIN s 0003-0006 apply to the following salient characteristics for Auditory Function Screening Devices. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 6 Must have multiple word recognition options. Literature Review SC 7 Must have QuickSIN, standard testing option, more options are advantageous. Literature Review SC 8 Built-in tools. Literature Review CLIN s 0007 apply to the following salient characteristics for Auditory Function Screening Devices. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 9 Impedance checks. Literature Review SC 10 Must be available with CE-Chirp stimuli. Literature Review SC 11 Data to screen options automated. Literature Review CLIN s 0008 apply to the following salient characteristics for Auditory Function Screening Devices. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 12 Must be able to do diagnostic and screening in Otoacoustic Emissions. Literature Review SC 13 Must be portable and rechargeable. Literature Review SC 14 Must have screening configurations preferably with DPOAE, TEOAE and combo DPOAE+TEOAE. Literature Review SC 15 Must have a minimum of fifteen (15) hours battery life. Literature Review SC 16 Must contain twelve (12) frequency DPOAE test and results display. Literature Review SC 17 Must have Data Manager Software. Literature Review SC 18 Must have Ear tip kit. Literature Review CLIN s 0009-0012 apply to the following salient characteristics for Auditory Function Screening Devices. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 19 Must have color touch screen interface. Literature Review SC 20 Must include shoulder probe mount. Literature Review SC 21 Must provide comprehensive standard protocols for diagnostic tests. Literature Review SC 22 Must offer built-in USB interface. Literature Review Definitions GSI 39 IPSI Reflex When a loud sound enters a normal ear, the stapedius muscle will contract on both sides regardless of which ear is stimulated. Therefore, the ART is a bilateral (""two side"") reflex. Third, the word ipsilateral (ipsi) means ""same side (contralateral (contra) means opposite side). A reflex in which the response occurs on the same side of the body that is stimulated. Tympanometry An examination used to test the condition of the middle ear and mobility of the eardrum (tympanic membrane) and the conduction bones by creating variations of air pressure in the ear canal. Tympanometry is an objective test of middle-ear function. Audiometry An exam tests your ability to hear sounds. Sounds vary, based on their loudness (intensity) and the speed of sound wave vibrations (tone). Hearing occurs when sound waves stimulate the nerves of the inner ear. The sound then travels along nerve pathways to the brain. GSI AUDIOSTAR PRO QuickSIN The primary complaint of hearing-impaired persons is difficulty hearing in background noise. The measurement of SNR loss (signal-to-noise ratio loss) is important because speech understanding in noise cannot be reliably predicted from the pure tone audiogram. The QuickSIN test was developed to provide a quick way for clinicians to quantify a patient s ability to hear in noise. SPEECH-IN-NOISE BKB SIN Bamford-Kowal-Bench Speech-in-Noise test. TEN Threshold Equalizing Noise Test dB HL Decibels Hearing Level Noah 4 The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks. TDH Telephonics Dynamic Headphone AUDERA CPT The CPT coding system describes how to report procedures or services and is maintained and copyrighted by the American Medical Association. Each CPT code has five digits (e.g., 92557). DPOAE Distortion product otoacoustic emissions (DPOAE) are responses generated when the cochlea is stimulated simultaneously by two pure tone frequencies whose ratio is between 1.1 to 1.3. TEOAE Transient-evoked otoacoustic emission tests provide a quick and objective test of the cochlea's outer hair cells. A series of transient stimuli (wideband clicks or chirps) are sent into the ear canal. ASSR Auditory Steady-State Response--- an objective test used for evaluation of hearing ability in children too young for traditional audiometric testing. Most children are referred for ASSR after a newborn hearing screen in the hospital indicates the possibility of hearing loss. AEP Auditory-Evoked Potential--- used to determine if specific parts of the vestibular system are functioning properly. Evoked potentials, sometimes called evoked responses, record the amount of time the nerves take to respond to electrical and sound stimulation. CAEP Cortical Auditory-Evoked Potential--- Evoked potentials are small electrical signals that are produced by the hearing pathways in the brain. The response is measured from the brain. They can be recorded from the surface of the head.
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